1. Field of the Invention
This invention relates in general to a laparoscopic surgical procedure for the treatment of morbid obesity and, more particularly, to a novel gastric band and a method for the laparoscopic placement of the band.
2. Prior Art
Methods that have been used in the prior art to treat morbid obesity include gastric bypass and small bowel bypass surgery. Stapling of portions of the stomach has also been used to treat morbid obesity. This includes both vertical and horizontal stapling and other variations which will reduce the size of the stomach and make a small stoma opening. Many problems have been associated with the use of staples. First, staples are undependable. Second, they may cause perforations in the stomach wall. And third, the pouch or the stoma formed by the staples may become enlarged over time making the procedure useless.
A more promising method employs the placement of a band around a portion of the stomach by open surgery thereby compressing the stomach and creating a stoma that is less than the normal interior diameter of the stomach. The constricted stoma restricts food intake into the lower digestive portion of the stomach. Such a band has been described by Kuzmak et al in U.S. Pat. No. 4,592,339. In its simplest form the gastric band comprises a substantially nonextensible belt-like strap which constrictively encircles the outside of the stomach thereby producing a new stoma and preventing it from expanding.
Although the banding procedure has great promise due to its simplicity and the fact that it retains the desired diameter of the stoma once established, it is necessary to establish a proper stoma size. To overcome this problem, Kuzmak in U.S. Pat. No. 4,696,288, describes a calibrating apparatus and method for using with a gastric banding device. The calibrating apparatus facilitates controlling the size of the stoma with the gastric band.
In the above-cited '339 patent Kuzmak et al also describe a band which includes a balloon-like section that is expandable and deflatable by injection or removal of fluid from the balloon through a remote injection site. The balloon-like expandable section is used to adjust the size of the stoma both intraoperatively and postoperatively. Such a device is referred to as a stoma-adjustable gastric band.
To facilitate the removal of a gastric band without the need for major surgery, Kuzmak, in U.S. patent application Ser. No. 07/562,391, filed Aug. 3, 1990, describes a gastric banding device with means thereon for removal of the band without the necessity for major surgery. The gastric band of the '391 patent application (referred to herein as a "reversible gastric band") has a actuator cord, one end of which (the distal end) is implanted in the right anterior rectus sheath of a patient, the other end being in contact with a means on the band for severing the loop about the stomach. In practice, the reversible gastric band is operatively placed to encircle the stomach by means of open major surgery. Once in position about the stomach, the reversible gastric band is held securely with sutures on the outside of the stomach thereby prohibiting the encircled stoma from expanding. If, following implantation, it becomes necessary or desirable to remove the reversible gastric band, a remotely actuated releasing portion on the band is activated by means of the actuator cord thereby permitting the removal of the gastric band without major surgery. In addition to having a remotely actuated releasing portion, most preferred embodiments of the reversible gastric band include a flexible substantially non-extensible band portion having an expandable, balloon-like section that is in fluid communication with a remote injection site. The expandable section is used to adjust the size of the stoma either during or following implantation.
Although the ability to adjust and/or remove the gastric band from the abdomen of a patient without the need for open major surgery is a great improvement in the art, it would be especially desirable (particularly from the patient's point of view) to provide a gastric band which may be both deployed in an encircling position around the stomach of a patient and removed from the abdomen without the need for open surgery.
Laparoscopy is a frequently used, relatively conservative modality for gaining entry to the abdominal cavity for diagnostic or therapeutic purposes. The recent popularity of laparoscopic cholecystectomy ("Laparoscopic Cholecystectomy: An Initial Report" by B. A. Salky, et al Gastrointestinal Endoscopy, Volume 37 No. 1, pp 1-4 (1991)) has further stimulated interest in laparoscopic surgical techniques and the development of surgical laparoscopic instruments.
The major patient benefits of laparoscopic surgical procedures are less trauma, less risk of pneumonia due to immediate ambulation, shorter hospital stay, and faster recovery time. Laparoscopic surgery eliminates the large abdominal incision and significantly decreases post-operative pain. Patients may be discharged the next day or even the same day and can resume normal activities within a week.
A laparoscopic surgical procedure is different than an open procedure because all manipulations are done using instruments through small diameter cannulas inserted into the peritoneal cavity through the abdominal wall. The procedure is technically more demanding than through an open incision, and, at least initially, may take longer as the team is learning the new technique. Not only are novel instruments needed for working through a cannula but the work itself must be observed on a 2-dimensional video display. Thus, the surgeon is unable to use the sense of touch and must perform surgery using novel instruments without the benefit of depth perception.
A major problem associated with inserting a prior art band laparoscopically around the stomach is the fact that the stomach is adhered to tissues posterior to the stomach and dissection of these posterior tissues laparoscopically appeared formidable. Potential problems include poor visibility, possible perforation of the stomach, damage to the surrounding organs, hemorrhage and vagus nerve damage. Placing and securely attaching prior art gastric bands laparoscopically would be very difficult or impossible These challenges have encouraged the present inventor to develop both a gastric band suitable for laparoscopic placement and a procedure for its deployment around the stomach. A stoma-adjustable gastric band adapted for laparoscopic placement about the stomach will be referred to herein as a "SLAP gastric band" or, alternatively, as a "SLAP band." Such a SLAP gastric band must be capable of being introduced into the abdominal cavity by means of a trocar cannula portal and deployed in an encircling position around the stomach by laparoscopic techniques.